# K230397: Cut Screw - Percutaneous Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Jun 12, 2023 after 118 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K792022 (1979). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143229: Nexis osteosynthesis compressive screws, Novastep (2015) Summary page 4.

## Indications for use
Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.

Source page: https://510kreport.com/device/K230397
Methodology: https://510kreport.com/methodology